Recruiting
Early Phase 1

ARC-001

Sponsor:

Arcato Laboratories, Inc.

Code:

NCT06864884

Conditions

Acute Post Operative Pain

Third Molar Extraction Surgery

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

ARC-001

Placebo gel

Study Details

Brief summary:

The study will test the investigational product gel against placebo (which contains no active ingredient) to determine if it is safe after wisdom tooth extraction. The main questions the study will answer are:

1. How much of the investigational product is absorbed in the blood?
2. Are there side effects?

Conditions

Acute Post Operative Pain

Third Molar Extraction Surgery

Study ID

NCT06864884

Start date

Feb 26, 2025

Status verified date

Mar, 2025

Completion date

Feb, 2026

Anticipated

Primary completion date

Feb, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Able to provide informed consent
  • In generally good health
  • BMI 18 to 38kg/m²
  • Scheduled to undergo wisdom teeth extraction

Exclusion Criteria:

  • Serious medical condition
  • Clinically significant abnormal lab values
  • Blood donation in the last 60 days, or plasma donation in the last 7 days.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ARC-001

0.75 mL gel emulsion with active ingredient applied once to the surgical site.

placebo comparator: Placebo

0.75 mL gel without active ingredient applied once to the surgical site.

Interventions

ARC-001

Gel formulation containing investigational anesthetic.

Placebo gel

Gel that contains no active ingredients.

Primary outcome measure

  • Safety and Tolerability [ Time Frame: 28 Days ]

Central Contacts and Locations

Locations

CenExel JBR

Recruiting

Salt Lake City, Utah, United States, 84107

Contacts

Recruiter

801-261-2000participate@jbrutah.com

More Information

Sponsor

Arcato Laboratories, Inc.

Last update posted

Mar 11, 2025

Last verified

Mar, 2025

Keywords

  • wisdom teeth surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Arcato Laboratories, Inc. on 2025-03-11.